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Project Topic
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The project “Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries (BERC-Luso)” engages 4 sub-Saharan African countries – Angola, Guinea Bissau, Mozambique and Cape-Verde –, working with their NECs and NRAs. It aims to develop and strengthen national medicines regulatory systems and capacities for ethical review of clinical research, in order to preserve public health interest, allowing pharmaceutical industry to pursue their activity, while respecting ethical and cultural values. Therefore, it responds directly and fully to the terms of the Call. Establishing and developing ethical/regulatory capacity through: • Work, at institutional level, with NECs/NRAs and, through them, with IECs/IRBs – improving institutional capacity to fully perform their mission, therefore, leading to their recognition and accreditation; • Work, at professional level, with different background professionals efficiently engaged in ethical review of clinical research, through accredited programs; • Involvement of legal action, by promoting the revision of NECs’/NRAs’ current legislation, integrating international good practices guidelines for ethical and regulatory revision; • Engagement of political action, aiming to mobilize Ministries of Health and Science support, implicated in public health development. Implementation includes: • Expert legal advice; • Theoretical/practical ethical and regulatory training; • Wide-ranging and content substantial networking, also anticipating long-term training of regulatory staff. Actions will converge into the promotion of good practices at assistance (NECs/IECs) and research (NRAs/IRBs) levels, developed within a transnational collaborative framework including NECs/NRAs from African countries and Portugal, with the support of WHO and UNESCO. These actions will be developed along 36 months, in Portugal and Cape-Verde, with initiatives in each of the African countries. BERC-Luso expects, in the envisaged countries, to: promote NECs/NRAs legal framework compliance with international standards of research and good clinical practices; strengthen NECs/NRAs functionality, recognition and performance; create an information repository for documentation, easily accessible, to support further training; become an example to other African countries. The expected impact is to have fully functioning and articulated NECs/NRAs, compliant with international good practices, and a body of professionals with accredited expertise. Project outcomes shall be communicated through media channels and compiled on the project website as a valuable tool for information dissemination. Also, the national broadcast television (RTP), through its African channel, is willing to assist the project, broadcasting its events to all Portuguese Speaking African Countries. BERC-Luso coordination is assured by the Portuguese Board, gathering complementary high-level ethical and regulatory competencies and establishing permanent assistance to the project unfolding by providing secretariat and IT consulting.
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